Recall Z-0848-2026— Fresenius Kabi USA, LLC

Name: FDA recall Z-0848-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-03

Class II · Ongoing

Class II FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2025-11-03. It names one FDA 510(k) clearance: K183311. Product: Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.. Reason: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set..

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-11-03
Firm location: North Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K183311 — Ivenix Infusion System (IIS)Ivenix, Inc.·cleared 2019-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Reason for recall

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Data sourced from openFDA. This site is unofficial and independent of the FDA.